Monday, November 12, 2012

Dissapointing test results for anti-Malaria drug RTS,S

The highly anticipated anti-Malaria drug RTS,S has completed its third round
of testing. Some of the results were disappointing but not bad enough to stop
development of the drug. The tests find that the drug reduces malaria illness
by a third in infants. That fell short of expectations for the drug because
RTS,S now has the same effectiveness as mosquito bed nets. The manufactures of
the drug say that the results mean that RTS,S will have to be given to children
a couple of times, once at birth and a booster shot later on.

The study, funded largely by the Bill & Melinda Gates Foundation,
is part of the largest malaria trial ever conducted, taking place in
seven African countries. Results were published Friday in the New England Journal of Medicine, a U.S. publication.

While still significant, the results were disappointing in having
followed surprisingly positive findings last year, when a similar study
suggested that RTS,S was almost twice as effective (47-56 percent) on
slightly older children, those five to 17 months old.

If this most recent phase could replicate that level of efficacy
among infants, researchers had hoped that RTS,S doses could become
incorporated into the standard round of initial vaccinations commonly
given to newborns – an approach that has now been proven safe.

“It’s a little frustrating that we’re seeing different levels of
protection in different age groups compared to last year and this year,”
Andrew Witty, the CEO of GlaxoSmithKline, a major drugs manufacturer
and one of the central partners in developing RTS,S, told journalists
Friday from London.

“As it turns out, this phase of study was not the final step that I
think many people might have hoped. But it’s an important step and takes
us further forward towards the goal we’ve been working toward over the
past 50 years … this remains the lead and most encouraging candidate
vaccine.”

Indeed, the new research constitutes the first time that scientists
have found such high efficacy for an anti-malarial vaccine for infants.
Witty notes that if the two rounds of study had been reversed, the
psychological impact would be far different and the findings would
undoubtedly have been widely lauded.

Further, the higher efficacy among the slightly older cohort remains
extremely important, given that scientists have found that this age
category has greater susceptibility to severe cases of malaria than do
infants. While the ease of a single early vaccination would have been
the most efficient scenario, researchers say they will now be looking
into additional strengthening options, such as giving toddlers a booster
later on.

“Two things are very, very encouraging,” Witty says. “One, the trial
is successful, despite the fact that it doesn’t achieve quite the high
level we would have hoped. Two, the benefit we’ve seen is higher than
bed nets, which themselves deliver about 30 percent gain over nothing.”